Big brand pharma on the hook for generic problems

Ed Silverman looks into the Alabama ruling that says a brand maker can be sued for harms caused by a generic version of a drug

Will Alabama turn into a judicial hellhole for the drug industry? To listen to Pfizer and the trade group that represents the US drug industry, a recent ruling by the Alabama Supreme Court almost guarantees such an outcome. Why? The court ruled that Pfizer can be sued by a man who claimed he was injured by a generic version of its Reglan (metoclopramide) heartburn medicine. And the drug maker purportedly failed to warn physicians about the risks.

The 8 to 1 decision has brand-name drug makers on edge. This is one of the few instances in which a court has found that a brand-name drug maker can be sued even though a consumer had taken a generic, suggesting that consumers will be encouraged to file still more such lawsuits, especially in the wake of a 2011 ruling by the US Supreme Court that has limited claims against generic drug makers.

In that ruling, the US Supreme Court decided generic drug makers are not required to strengthen labeling if alerted to side effects, even when the same change has not been made to the labeling for the branded medicine. The decision has meant that generic drug makers cannot be sued for not alerting patients to such risks.

The issue in this case is whether an Alabama man named Danny Weeks can sue Pfizer for not warning about the risks of long term use. Weeks had taken a generic version of Reglan between 2007 and 2009, and later developed tardive dyskinesia, which causes incurable and involuntary muscle movements. However, the drug was never approved for use for longer than 12 weeks.